India

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11 01, 2013

How will be the impact on clinical trials in India for 2013?

By | 2016-10-20T17:41:24+00:00 January 11th, 2013|Categories: News|Tags: , , , , , , , |

Reference: FierceCRO | 01.07.13 | Indian court: Trials wreaking 'havoc Indian Supreme Court: Unregulated trials causing 'havoc' The clamor for reform of India's clinical trial regulations has reached a fever pitch over the past year, and now the country's Supreme Court is ordering the Health Ministry to keep a close eye on applications for new studies. The court heard a case claiming that many patients around the country were [...]

15 09, 2011

Delays in licensing approvals in India

By | 2016-10-10T17:05:59+00:00 September 15th, 2011|Categories: News|Tags: , , , |

Marketing licenses for biotechnological drugs as well as those used in clinical trials are being rejected by India’s apex pharmaceutical regulator, known as the DCGI, or Drugs Controller General of India. In the last year they have tightened the mechanism for approval on all fronts for therapeutic agents. Both domestic and multinational companies are facing much regulatory scrutiny and are often asked to make some changes in order to be [...]